Historically, gastro-intestinal (GI) surgery has been performed to create a channel or anastomosis between two viscera for the purpose of redirecting bodily fluids. For example, intestinal contents or bile may be redirected in patients who have developed an obstruction of the bowel or bile duct due to such conditions as tumors, ulcers, inflammatory strictures or trauma. During surgery to form an anastomosis, the two tissues are often brought together using devices such as sutures, staples, or some other fixation means such as adhesives. While the tissues are being brought together during the procedure, various types of surgical instruments may be used to temporarily hold the tissues in place. In open surgery, the temporary holding may be accomplished with graspers, forceps, or other tissue holding instruments that are manipulated by clinicians. In laparoscopic surgery, similar instruments may be used, except that the laprotic access limits the number of instruments that may be inserted into the site making the tissue securing procedure much more challenging.
When these types of GI surgery are performed, there exists the potential to breech the mural boundary. Thus, extreme care must be taken to prevent contamination of the pleural and abdominal cavities with GI contents, which are laden with bacteria that do not naturally occur in those locations. If significant contamination occurs, then serious infection can set in, which can lead to serious illness or death if not treated early and vigorously.
To address these limitations and to minimize the invasiveness of such surgeries, magnetic anastomosis devices (MADs) have been developed for forming anastomoses. An exemplary MAD is disclosed in U.S. Pat. No. 5,690,656, the disclosure of which is incorporated herein by reference in its entirety. Generally, the MAD of the '656 patent includes first and second magnet assemblies including magnetic cores that are surrounded by thin metal rims. The first and second magnet assemblies are positioned in the two viscera between which the anastomosis is desired and brought into close proximity to each other. Due to the magnetic attraction between the two magnetic cores, the walls of the two adjacent viscera are compressed between the magnet assemblies and in particular the magnetic rims, resulting in ischemic necrosis of the walls to produce an anastomosis between the two viscera.
MADs may be delivered through surgical intervention such as laparatomy, over a wire guide using a pushing catheter (and typically under fluoroscopy), by simply swallowing the magnet assemblies of the MAD and using massage under fluoroscopy to align the two magnet assemblies, or endoscopically using grasping forceps. Within about ten days after the visceral tissues surrounding the magnets fuse together, and the magnets and entrapped necrotic tissue subsequently detach from the surrounding tissue to leave an opening between the viscera.
In some patients, the obstruction may cause painful restriction of fluid flow through a body passage that requires a more immediate opening than is typically provided with the MADs. For example, the flow of bile from the liver may be obstructed through the bile duct due to a tumor or other blockage. There exists a need to rapidly restore the fluid flow to release the bile from the duct. Typically, a blockage in the common bile duct can be alleviated by inserting a drainage stent through the Ampula of Vader into the common bile duct to create an opening through the obstruction. However, drawbacks may arise when using a drainage stent inserted through the Ampula of Vader, including obstruction of the drainage stent. In addition, drainage stents periodically need to be changed to maintain the passage and fluid flow out of the bile duct, requiring additional patient procedures.
There is a need for devices and methods for immediate decompression of a duct and subsequent anastomosis.